Senior GMP Manufacturing & AI Advisor (remote)

................ For our client in Zurich, we are looking for an experienced Senior GMP Manufacturing & AI Advisor (remote). We are looking for an professional who combines deep GMP manufacturing expertise with hands-on experience in Artificial Intelligence within regulated pharmaceutical environments. The ideal candidate will act as a trusted advisor, helping to identify, assess, and implement AI-driven improvements across manufacturing and quality processes. Your Tasks: " Analyze the end-to-end autogenous vaccine development process and identify operational bottlenecks, inefficiencies, and decision-making challenges " Assess opportunities for AI-driven solutions, including predictive analytics, document automation, workflow optimization, and decision support systems " Develop and prioritize AI initiatives based on feasibility, business value, and implementation potential " Support the establishment of a regulatory-compliant organization aligned with current and emerging AI regulations " Evaluate manufacturing sites and recommend pilot locations based on maturity assessments and operational readiness " Conduct stakeholder interviews and present executive-level recommendations and roadmaps " Contribute to the development of pilot programs and scalable AI deployment strategies within GMP-regulated environments Your Profile: " 12+ years of hands-on GMP manufacturing experience within the pharmaceutical, biotech, or animal health industry " Proven operational experience in Production, Quality Assurance, MS&T, or Engineering, including batch execution, deviation management, and regulatory inspections " Demonstrated experience delivering AI or advanced analytics use cases within GMP environments during the last 24 months " Expertise in Generative AI or AI agent solutions within GxP-regulated processes " Strong knowledge of AI/ML validation, data integrity, and compliance frameworks including GAMP 5, CSA, 21 CFR Part 11, EU Annex 11, and ALCOA+ " Experience conducting manufacturing site assessments and advising senior leadership teams " Up-to-date knowledge of evolving AI-related pharmaceutical regulations and GMP requirements " Excellent communication and stakeholder management skills, with the ability to present complex topics to executive audiences " Fluent in English Find Jobs in Switzerland on Arbeitnow